www.hivandhepatitis.com

EASL 2014: European Liver Specialists Recommend Use of Newest Hepatitis C Drugs

The European Association for the Study of the Liver (EASL) has issued new guidelines for the treatment of hepatitis C, which recommend that wherever possible, patients should be treated with the newest direct-acting antivirals. The guidelines also recommend physicians should "mix and match" antivirals from different companies to get the most potent regimens.

[Produced in collaboration with Aidsmap and infohep]

The panel that developed the guidelines discussed their recommendations and implications for hepatitis C treatment in Europe and worldwide at EASL's International Liver Congress this week on London. The full guidelines can be downloaded from the EASL website.

The guidelines move beyond U.S. recommendations issued in January, which incorporated a small number of off-label uses not included in the FDA licenses for sofosbuvir (Sovaldi) and simeprevir (Olysio). The new EASL guidelines also include daclatasvir, a NS5A inhibitor that is likely to receive approval in Europe later this year.

EASL is encouraging European physicians to combine products from different pharmaceutical companies to achieve the most potent interferon-free regimens, often in advance of full Phase 3 trial data.

Guidelines panel chair Jean-Michel Pawlotsky, director of the French National Reference Centre for Viral Hepatitis B, C and Delta, told reporters that the EASL guidelines were designed to accommodate the diversity of European populations and reimbursement practices. The guidelines were also designed to empower physicians to obtain permission to use new agents under compassionate access arrangements prior to licensing, said Alessio Aghemo, a member of EASL’s Scientific Committee and a professor of medicine at the University of Milan.

The EASL guidelines are another sign that when making prescribing decisions for patients with hepatitis C, physicians do not intend to be constrained by licensing indications or the quest of pharmaceutical companies to deliver "exclusive" drug combinations that require prescribers to use co-formulated direct-acting antivirals from a single company.

The guidelines make recommendations for all HCV genotypes, and include all direct-acting antivirals that are expected to be licensed in Europe during 2014, including the HCV protease inhibitor simeprevir and the NS5A inhibitor daclatasvir. Simeprevir is likely to receive marketing approval in May 2014 and daclatasvir in September 2014. Sofosbuvir was already approved in January 2014.

Bristol-Myers Squibb, the developer of daclatasvir, has anticipated the European move towards a "mix and match" approach by applying for a license for daclatasvir alone in Europe. In the U.S., it is seeking a license for daclatasvir in combination with its protease inhibitor asunaprevir.

The EASL guidelines recommend that the first-generation protease inhibitors telaprevir (Incivek or Incivo) or boceprevir (Victrelis) should be used for treatment of genotype 1 HCV infection only when newer options are not available. For other genotypes, the combination of pegylated interferon and ribavirin is described as "acceptable" where newer options are not available.

The guidelines will be updated as soon as approval dates for new interferon-free combinations of sofosbuvir/ledipasvir (Gilead Sciences) and ABT-450/ritonavir, ombitasvir, and dasabuvir (AbbVie) are known. These are likely to be approved in early 2014.

4/13/14

Reference

European Association for the Study of the Liver. EASL Recommendations on Treatment of Hepatitis C. http://files.easl.eu/easl-recommendations-on-treatment-of-hepatitis-C/index.html. April 2014.

Other Source

European Association for the Study of the Liver. EASL publishes on-line recommendations on the management of hepatitis C. Press release. April 9, 2014.